Drugs

Congress Should Legislate on Generic Label: Editor

JAMA deputy editor Gregory Curfman says it is “troublesome” that in most jurisdictions, both generic and innovator drug companies are protected from legal liability stemming from failure-to-warn claims. “Congress should fully consider this issue and fill the gap in the current legal framework through legislation,” he writes in a 7/23 online Viewpoint column.

The article looks at the few state courts that have addressed the issue of whether a consumer injured by a generic drug should be able to bring legal action against a brand manufacturer that negligently, recklessly, or intentionally failed to warn of known adverse drug effects that cause injury.

A recent Massachusetts decision, he says, is the latest example of a state court holding that a brand-name manufacturer failing to update a warning label with relevant safety information may be held liable. “The court justified its decision on the basis of public policy concerns for the safety of consumers while also considering the legal burden on brand-name manufacturers,” Curfman says.

The article notes that FDA proposed a rule in 2013 that would have allowed generic drug manufacturers to update product labels to reflect new drug safety developments, but received significant pushback and has not published a final rule.

“In light of FDA’s failure to act,” he concludes, “the state court opinions endorsing innovator liability are especially important.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome